Method and apparatus for valving body fluids

ABSTRACT

A method and apparatus for valving body fluids involving a flexible tubular body with a drainage canal therethrough, including collapsible means for blocking the passageway and thereby preventing the flow of urine. The length of the device is such that one end protrudes into the bladder and the other end terminates interior of the meatus. The device includes a means for anchoring to secure it in place and a plug device for deflating and releasing the anchoring means and for collapsing the blocking means to facilitate removal of the device from the body. The device is manually actuable to an open position and means are provided to delay the closing of the device for a sufficient period of time to allow voiding of the bladder. The collapsible and expandable nature of the device facilitates its insertion and removal, particularly while passing through areas of restricted diameter.

This is a continuation of application Ser. No. 267,748, filed on Nov. 2,1988, now U.S. Pat. No. 4,909,785 which is a continuation of U.S. Pat.No. 843,747 filed on Mar. 25, 1986, now abandoned.

BACKGROUND OF THE INVENTION

The present invention relates generally to methods and apparatus forvalving bodily fluids, such as urine, and particularly to urethraldrainage catheters for controlling discharge of fluid from the bladderand more and particularly to a device which is completely implantedwithin the bladder and adjacent portions of the urethra.

1. Field of the Invention

Urinary incontinence is a serious and long-recognized problem in themedical field, and much effort has been directed to providing devicesfor handling the problem. The number of patents granted in this fieldare evidence of such efforts.

Urinary incontinence is the inability to voluntarily control theelimination function of the bladder. This problem can result fromnumerous causes, including old age, disease, trauma, or some form ofneurological dysfunction, and the problem is generally incurable. Thepatient suffering from urinary incontinence may experienceembarrassment, discomfort, and loss of self-esteem. In addition, normalhuman activity may be severely limited.

Attempts to alleviate this problem have generally involved eitherexternal or external/internal devices. Examples of external devices areadult diapers and urine alarms. External/internal devices such asurinary catheters have also been studied. However, such catheters have alimited indwelling life because of the likely onset of serious urethralinfections. The operation of such devices is also severely complicatedby the very limited diameter of the urethra. These and othercomplications have made elusive the search for an indwelling urinecontrol device that achieves comfortable, convenient and relatively"normal" bladder control for the incontinent patient.

2. Description of the Related Art

Numerous devices have been developed to facilitate the controlleddischarge of the urinary bladder, one of the most common being aurethral catheter extending from the bladder, through the entireurethral tract, to the exterior of the body. The catheter is ordinarilyinserted into the bladder and retained in position by inflatable cuffsor balloons. A drainage passageway extends the length of the catheter,allowing urine to flow from the bladder to the atmosphere. The drainagepassageway may, alternatively, be connected to a collector bag orinclude a shut-off valve for controlling the passage of urine. U.S. Pat.Nos. 3,642,004 ("Osthagen"), 3,811,450 ("Lord"), and 4,022,216("Stevens") are representative of such devices.

The Osthagen, Lord, and Stevens devices have numerous well-knowndisadvantages, not the least of which is susceptibility to infection.The protruding catheter provides an ideal path for migration of bacteriainto the bladder, possibly resulting in extreme complications. Further,the use of collector bags can be both uncomfortable and embarrassing,adversely affecting the wearer's psyche. Finally, use of devices whichextend beyond the urethra restricts or prohibits normal activities.

Another approach to the problem of controlling urinary incontinence hasbeen to provide a means for constricting the urethra to block the flowof urine, with the capability of selectively releasing the constrictionto allow voiding of the bladder. Such devices are described in U.S. Pat.Nos. 3,939,821 ("Roth") and 3,750.,194 ("Summers"). The most commonproblems associated with the use of a constricting device are impairedcirculation, edema, and urethral diverticulum.

Still other methods have been developed to control urinary incontinenceby using completely indwelling devices. U.S. Pat. Nos. 3,768,102("Kwan-Gett") and 3,797,478 ("Walsh") describe devices which rely onnormal voiding pressure being exerted by the wearer to overcome athreshold resistance and start the flow of urine. The devicesautomatically return to a closed state upon evacuation of the bladder.Another such device is shown in application Ser. No. 6-550,040, filed byStephen B. Leighton ("Leighton").

Other indwelling urethral catheters have incorporated valves which areactuated by external forces. U.S. Pat. No. 3,812,841 to Isaacson("Isaacson") shows a urethral valve which is implanted in the urethra atits point of entry into the bladder. Inflatable collars hold thestructure in place while a valve internal to the device prevents theflow of urine through the drainage canal. The valve is magnetic innature and responds to a magnetic field generated at the exterior of thebody. The external field causes the valve to open, thus allowing thebladder to be voided through the urethra, and removal of the field thenallows the valve to return to a closed position. The numerous mechanicalparts of the Isaacson valve increase the possibility of malfunction ofthe unit and consequential repair or replacement. Further, the physicalsize and relative inability of the catheter to collapse, being of"slightly flexible deformable plastic" and sufficiently large toobstruct the urethra near the bladder, present extreme difficulties ininsertion and removal.

U.S. Pat. Nos. 4,350,161 and 4,432,757, both to Davis, Jr. ("Davis")show an indwelling urethral catheter used by males which is secured inthe bladder by a Foley-type balloon and which extends the length of theurethra to the penile urethra. A valve is mounted in the distal end ofthe catheter and is normally biased to a closed position. The valve isactuable to an open position by external hand manipulation of the penis.Although the Davis catheter does not extend to the penile meatus, itoccupies a significant portion of the penile urethra. Such a positionreduces the length of urethra which is subject to the normal flushing ofurine and may invite migratory infections. Further, location of thedistal end of the catheter and the valve in the penile urethra mayresult in considerable discomfort upon expansion and contraction of thepenis, as upon erection. Finally, as in Isaacson, the rigid valvestructure can be a source of considerable discomfort and trauma both ininsertion and removal and during normal usage.

One object of the present invention is to overcome many of theabove-mentioned drawbacks by providing a manually actuated urinarycontinence device which is completely indwelling within the urinarytract, thereby reducing the possibility of infection associated withmany of the prior devices.

SUMMARY OF THE INVENTION

According to the present invention, a method and apparatus for valvingbodily fluids may involve a device which is intended to be located inthe urethra between the bladder and the penile meatus. The device doesnot extend outside the penis and thereby may provide protection againstinfection. The device is secured in place by means of inflatableballoons located generally in the bladder and in the proximal urethraarea, inhibiting significant movement along the urethra in eitherdirection.

A drainage passageway extends the length of the device and facilitatesevacuation of the bladder. The passageway is blocked by a collapsiblevalve which is manually actuable to an open position. Once opened, thevalve remains open for a short period of time to allow evacuation of thebladder and, after the delay, automatically returns to its closedposition.

The valve is collapsible from its normal shape to allow ease ofinsertion through areas of restricted diameter in the urethra. Whenproperly positioned, the valve resumes its normal shape, increasing itscross-sectional area and, thus, the flow area therethrough.

An insertion tool attaches to the device for insertion into thepatient's urethra, inflating the balloons which hold the device inplace, thereby inflating the collapsible valve. Inflation passages inthe insertion tool communicate with the device via self-sealing valves,or septums. Following insertion of the device and inflation of theballoons and collapsible valve, the insertion tool is withdrawn from theurethra, leaving the device in place. The self-sealing valves preventdeflation of the balloons and valve upon withdrawal of the insertiontool.

The device is removable from the urethra generally by means of acystoscope or similar device. A plug at the distal end of the device isgrasped by the withdrawal tool and pulled, allowing deflation of theballoons and collapsible valve and providing a means for withdrawing thedevice from the urethra. Alternatively, a monofilament cord, or similardevice, may be attached to the plug and allowed to extend outside theurethra to be grasped and pulled to deflate the balloons and valve andfacilitate removal of the device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one preferred embodiment of the present invention asit is positioned in the male urethra with the insertion/inflation toolattached.

FIG. 2 is a view of the device of FIG. 1 as sectioned along itslongitudinal axis showing the balloons and valve in inflated conditionswith the insertion/inflation tool attached.

FIG. 3 is a cross-section of the device taken along lines 3--3 in FIG.2.

FIG. 4 is a cross-section of the device taken along lines 4--4 in FIG.2.

FIG. 5 is a cross-section of the device taken along lines 5--5 in FIG.2.

FIG. 6 is an enlarged, longitudinal section view of bleed-back device 40shown in FIG. 2.

FIG. 7 is a perspective view of one embodiment of an insertion tool thatmay be used with the present invention.

FIG. 8 is a view of the device as sectioned along its longitudinal axisshowing the plug removed and the balloons and valve in deflatedconditions.

DETAILED DESCRIPTION

FIG. 1 illustrates one embodiment of a device 10 of the presentinvention positioned within the male urethra 17. Inflatable balloons 11and 12, located within the bladder 13 and the proximal urethra,respectively, anchor the device 10 in place and secure it againstsignificant movement in either direction. A valve assembly 15 is locatedbelow inflatable balloon 12 and, when inflated, obstructs the urinarypassage 21 (shown in FIG. 2) within the device 10 to prevent the flow ofurine from the bladder 13.

The location of the valve assembly 15 is variable, as is the overalllength of the device 10, and FIG. 1 illustrates only one embodiment ofthe invention, that being the preferred embodiment. In this embodiment,as noted above, inflatable balloons 11 and 12 are located in the bladderand proximal urethra and valve assembly 15 is located in the region ofthe bulbous urethra.

Referring now to FIG. 2, a preferred embodiment of device 10 generallycomprises a tubular body 20 with a balloons 11 and 12 serve to anchorthe device 10 within the bladder and urethra and valve assembly 15controls the flow of urine through passageway 21.

Tubular body 20 is preferably formed of a flexible material, forexample, silicone, to facilitate insertion and removal of the device aswell as to decrease the discomfort normally associated with the use ofsuch a device. The material should preferably be biocompatible so as notto cause complications within the urinary tract. The diameter of tubularbody 20 is very restricted so that it will easily pass throughrestricted regions of the urethra.

As noted above, tubular body 20 contains a passageway, or lumen, 21extending longitudinally the length of device 10. A port 27, located atproximal end 26 of device 10-, allows for the entry of urine intopassageway 21.

Located adjacent port 27 is inflatable balloon 11. The balloon 11 isformed from a resilient and stretchable material and comprises a tubeconcentric about body 20 with a diameter approximating that of body 20.The upper and lower ends of balloon 11 are affixed at points X and Y tothe exterior surface of body 20 by means of a silicone adhesive, orsimilar means. The central portion of balloon 11 is thus expandable inresponse to internal pressurization to form a circumferential barrier,or cuff, about tubular body 20. Balloon-filling port 18 penetrates theside wall of body 20 and is longitudinally situated between the upperand lower peripheries of balloon 11, points X and Y. Within tubular body20 and in communication with port 18 is a second longitudinalpassageway, or lumen, 31, which will be more fully described below.

Spaced longitudinally from balloon 11 is fixation balloon 12. Balloon 12is formed in a manner similar to that of balloon 11 and is affixed inlike manner to the exterior of body 20 at points W and Z, thus forming asecond circumferential barrier, or cuff. Balloon-filling port 19, as inthe case of port 18, penetrates the side wall of body 20 and islongitudinally situated between the upper and lower peripheries offixation balloon 12, points W and Z. Contained within tubular body 20and in communication with port 19 is a third longitudinal passageway 32,which will be more fully explained below.

Near distal end 28 of device 10 is a collapsible valve assembly 15. Theassembly 15 generally comprises an inflatable bulb 34, ports 36, andflexible sheath 33. The sheath 33 is formed from a semi-resilientmaterial similar to that of body 20 and balloons 11 and 12 and is of atubular construction. The sheath 33 fits over the distal end 28 oftubular body 20, forming an annular space therebetween, and its proximalend 42 is permanently affixed about the circumference of body 20 using asilicone adhesive or similar means.

Sheath 33 is pre-formed in a shape resembling an ellipse so that itsdiameter at its central region is greater than its diameter at eitherend. This is most easily seen in FIGS. 2 and 8. When in its normalcondition, the sheath 33 forms an annular space about the body 20 whichis typically larger in cross-sectional flow area than the annular spacedefined when the sheath 33 is collapsed against the body 20, as whenpassing through areas of restricted diameter.

Contained within the annular space formed between body 20 and sheath 33is an inflatable bulb 34. The bulb 34 is formed in like manner toballoons 11 and 12 and is affixed to the exterior of the body 20 in asimilar manner. The valve ports 36 penetrate the side wall of tubularbody 20 and provide fluid communication between the interior of bulb 34and valve control passage 35, which will be more fully explained below.

FIG. 2 illustrates the locations and interconnections of passages 21,31, 32, and 35. Longitudinal passageway 21 extends from port 27 atproximal end 26 of device-10, along the longitudinal axis of body 20 tothe proximal end 42 of sheath 33. The annulus formed between the sheath33 and tubular body 20 creates an extension of urinary passageway 21from the proximal end 42 of sheath 33 to the distal end 28 of device 10.Balloon-filling passage 31 extends along the longitudinal axis of body20 from proximal end 26 to distal end 28 of device 10. As explainedabove, passage 31 is connected to the interior of inflatable balloon 11by means of port 18. At its proximal end, passage 31 is connected toflow control mechanism 38, the structure of which will be more fullyexplained below. Balloon-filling passage 32 is also situated along thelongitudinal axis-of body 20 and extends from fixation balloon 12 todistal end 28. Again as explained above, the passage 32 is connected tothe interior of fixation balloon 12 by means of the port 19. Valvecontrol passage 35 is situated along the longitudinal axis of body 20and extends from proximal end 26 to chamber 22 near the distal end 28.At its proximal end, passage 35 is connected to flow control mechanism38. Ports 36 provide fluid connection between passage 35 and theinterior of inflatable bulb 34.

Inflatable bulb 34 in its inflated condition presses against sheath 33,as shown in FIGS. 2 and 3. The body 20 is substantially oval-shaped inits cross-section and contains passages 31, 32, and 35. A port 36,illustrated in FIG. 3, connects valve control passage 35 with theinterior of inflatable bulb 34.

Referring to FIG. 4, the body 20 is generally circular in cross-sectionin the area of fixation balloon 12 and contains the semi-circularurinary passageway 21 and the pie-shaped balloon-filling passages 31 and32, and valve control passage 35. The general shape and configuration ofthe various passages provides for optimal use of the restricted diameterof body 20; however, other shapes and arrangements may be used. It ispreferred that the diameter of body 20 be minimized for reasons whichwill be more fully explained below. The port 19 connects theballoon-filling passage 32 with the interior of fixation balloon 12.

The portion of body 20 near the balloon 11 contains urinary passageway21, balloon-filling passage 31, and valve control passage 35, as shownin FIG. 5. Port 18 connects balloon-filling passage 31 and the interiorof inflatable balloon 11. The balloons 12 and 11 are concentric withthe-circumference of body 20. FIG. 3 illustrates that both inflationbulb 34 and sheath 33 are circumferential about body 20 and areconcentric with one another.

Flow control mechanism 38 is located within tubular body 20 at itsproximal end. The mechanism 38 comprises two primary elements. A checkvalve 39 is connected at one end to balloon-filling passage 31 and atits other end to valve control passage 35. Check valve 39 allows one-wayflow of fluid from passage 35 into passage 31 but will not allow fluidto flow from passage 31 to passage 35. Bleed-back device 40 is connectedto passages 31 and 35 and is connected in parallel to check valve 39.Bleed-back device 40, as used in one embodiment, is illustrated in FIG.6 as a screw 43 loosely threaded into port 44. Threads 46 in port 44generally provide a loose fit with threads 45 on screw 43, resulting ina helical flow path from passage 31 to passage 35. The operation of flowcontrol mechanism 38 will be explained in detail below.

The chamber 22 is located at distal end 28 of device 10 and is generallycylindrical in shape. The cylindrical chamber is formed along thelongitudinal axis of body 20 and extends from adjacent inflatable bulb34 to the distal end 47 of tubular body 20. At one end, chamber 22 isopen to the exterior of body 20 and, at its other end, chamber 22 isconnected to passages 31 and 32 by means of vents 23 and 24,respectively. Passage 35 terminates, at its distal end, in chamber 22.Chamber 22 is configured to accept a generally cylindrical plug 25. Plug25 fits within chamber 22 to obstruct vents 23 and 24 and the distal endof passage 35. The plug 25 may be attached to body 20 by means of asuture 41 looped about the circumference of body 20, as shown in FIG. 2.

Also located at distal end 28 of device 10 are self-sealing valves, orseptums, 29 and 30. As explained above, balloon-filling passages 31 and32 extend along the longitudinal axis of body 20 to distal end 47 ofbody 20. Self-sealing valves 29 and 30 may be formed from any resilientsubstance which may be penetrated by a needle and which will collapseupon itself upon withdrawal of the needle. In the preferred embodiment,that substance is silicone. Valves 29 and 30 generally resemble siliconeplugs located within the distal ends of balloon-filling passages 31 and32.

The operation of device 10 may be substantially as follows:

Prior to insertion into the urethra, device 10, representing a preferredembodiment of the present invention, is in a completely deflated state.Balloons 11 and 12 and bulb 34 are collapsed against the exterior ofbody 20. Sheath 33 is in its normal shape, bulged away from body 20.Plug 25 is inserted into chamber 22, obstructing vents 23 and 24, andpassageway 35, preventing flow of fluid therebetween.

Insertion tool 50, illustrated in FIG. 7, is attached to the distal end28 of device 10. Needles 51 and 52 penetrate self-sealing valves 29 and30, and sleeve 55 on the distal end 28 of device 10 fits snugly aroundthe proximal end 55 of insertion tool 50. Insertion tool 50 is generallyin the configuration of a Foley-type catheter, with certain importantmodifications, and is made of a flexible material such as that used indevice 10. Although the Foley-type catheter is generally known to thoseskilled in the art, the tool 50 departs from construction of the typicalFoley-type catheter in certain important ways, particularly in thearrangement of the proximal end 55.

After insertion tool 50 has been attached to device 10, the device isguided into and along the urethra into its proper position. Because ofthe small diameter of device 10 and the collapsible nature of balloons11 and 12 and valve assembly 15 (including sheath 33 and bulb 34), thedevice is easily maneuverable through relatively narrow areas commonlyfound in the urethra, especially the urethral meatus. Sheath 33, beingof a flexible material, collapses from its normal shape to lay againstbody 20 and substantially eliminate the trauma normally associated withinsertion of intraurethral devices.

Once it is properly positioned, device 10 is completely within theurethra, while the insertion tool 50 protrudes therefrom. Proximal end26 of device 10 has protruded into the bladder. Valve assembly 15 andsheath 33, when the device 10 is properly positioned, are located in agenerally enlarged area of the urethra, and sheath 33 assumes itspre-formed, bulging shape, thus enlarging the annular space formedbetween sheath 33 and body 20, resulting in an enlarged flow area invalve assembly 15.

A syringe generally used with Foley-type catheters is attached to theinsertion tool at points 53 and inflation fluid is injected throughself-sealing valves 29 and 30. A radiopaque fluid is preferred tofacilitate post-insertion x-ray and viewing of the device while in thebody. For example, Hypaque-25 or Renografin-60, aqueous dilutionsthereof, or equivalents, may be used as the radiopaque fluid.Alternatively, a relatively compressible fluid may be employed in analternate embodiment.

After the device 10 has been properly positioned within the urethra withits proximal end 26 protruding into the bladder, inflation fluid isinjected through self-sealing valve 29, along passageway 31, and intoballoon 11, located within the bladder. As balloon 11 is inflated, adifferential pressure begins to develop across flow control mechanism38. Check valve 39 is oriented so as to prevent the flow of fluid frompassage 31 into passage 35; however, bleed-back device 40 will allow agradual helical flow of fluid along threads 45 and 46 from one passageto the other. As a result of the pressure differential across mechanism38, inflation fluid begins to gradually flow through bleed-back device40 and into and through valve control passage 35. Fluid continues toflow through ports 36, filling bulb 34 and causing it to begin to expandagainst sheath 33. Because plug 25 is positioned within chamber 22,obstructing the distal end of passageway 35, fluid cannot escape fromvalve assembly 15. Sufficient fluid is injected through self-sealingvalve 29 and into passage 31 such that, when fluid pressure is equalizedbetween balloon 11 and bulb 34 and flow through bleed-back device 40ceases, balloon 11 is inflated to secure device 10 within the bladderand bulb 34 is pressed against sheath 33, blocking passage 21.

Because sheath 33 is resistively expandable, it will begin to expand asbulb 34 expands under pressure from the inflation fluid. However, thesheath 33 offers resistance to or bias against continued expansion ofbulb 34, creating an effective seal within the annular space betweenbulb 34 and sheath 33. By varying the volume of inflation fluid injectedthrough self-sealing valve 29, the effectiveness of the seal betweensheath 33 and bulb 34 can be varied.

Because the valve 15 operates by radial expansion, a relatively largearea of sealing contact between sheath 33 and bulb 34 may be achieved.This large contact area improves the sealing efficiency of the valve 15.

When the predetermined volume of fluid has been injected into balloon11, a slight pull on the insertion tool serves to seat the device at thebladder neck. This anchoring prevents migration of the device from thebladder. The syringe is then used to inject inflation fluid throughself-sealing valve 30, along passage 32, through port 19, and intoballoon 12. Sufficient fluid is injected to adequately secure the device10 in its proper position. Additionally, balloon 12 serves to seal theannular region formed between the tubular body 20 of device 10 and theurethra, thereby helping to prevent leakage of urine along the exteriorwall of device 10.

When the device 10 has been properly inflated, the insertion tool isdisconnected from the device with a steady pull and is withdrawn fromthe urethra. As the insertion tool is disconnected from device 10,needles 51 are withdrawn from self-sealing valves 29 and 30 and theirself-sealing nature seals the holes created by penetration of theneedles. The inflation fluid is thus prevented from escape from device10.

The seal created between sheath 33 and bulb 34 obstructs longitudinalpassageway 21 and prevents the flow of urine from the bladder throughthe passageway. However, in the event bladder pressure exceeds theinflation fluid pressure at the seal, "leak through" can occur. Indeed,such a capability may be desired in order to signal the need for voidingthe bladder. If "leak through" is not desired, pressure at the seal maybe increased by injection of a greater volume of inflation fluid. Again,the point at which "leak through" will be allowed can be controlled bythe volume of inflation fluid injected.

When voiding of the bladder is desired, device 10 is operated asfollows:

Valve assembly 15 is palpated by manually pressing a point external ofthe body in the area of the assembly. In the preferred embodiment, valveassembly 15 is located near the perineum, as shown in FIG. 1, andupwardly directed manual pressure on the perineum is transmitted via theurethral wall to sheath 33 and bulb 34. Inflation fluid is pumped frombulb 34 through ports 36 and valve control passage 35. Fluid readilyflows through check valve 39 and into passage 31.

Because vent 23 is obstructed by plug 25, the fluid is forced intoballoon 11, causing it to expand. Balloon 11, therefore, functions as atemporary reservoir for the fluid pumped from bulb 34. As bulb 34becomes collapsed or deflated, the seal between it and sheath 33 iseliminated, opening the longitudinal passageway 21 and allowing urine toflow from the bladder through the device to the exterior of the body. Inaddition, because bulb 34 has been deflated and balloon 11 is expandedwith filling fluid, a pressure differential is created across bleed-backdevice 40, causing a gradual flow of fluid to return to bulb 34.

In another embodiment, using a compressible inflation fluid, reservoir11 may not expand beyond its normal anchoring size, but rather maycompress the inflation fluid as it is received. The reduced fluidpressure in bulb 34 will allow it to collapse as above and the increasedpressure in reservoir 11, created by the compression of the fluid, willeffectuate the differential pressure necessary to cause the gradual flowof fluid from reservoir 11 to bulb 34.

Returning to the illustrated embodiment, this gradual flow continuesuntil the pressure between balloon 11 and bulb 34 is once againequalized. The return of fluid from balloon 11 to bulb 34 throughbleed-back device 40 is gradual enough so as to allow ample time for thebladder to void. During normal operation of device 10, fixation balloon12 is unaffected and maintains its anchoring effect and seal against theurethral wall.

When device 10 is to be removed from the urethra, a cystoscope, orsimilar tool, is used to pull the plug 25 from its position withinchamber 22, as indicated in FIG. 8. Balloons 11 and 12 are emptiedthrough passages 31 and 32, vents 23 and 24 and chamber 22. In addition,inflation fluid contained in bulb 34 is allowed to escape through ports36, valve control passage 35, and chamber 22. Balloons 11 and 12 andbulb 34 become collapsed and valve assembly 15 becomes readilycollapsible, facilitating removal of the device from the urethra. Theplug 25 is connected to device 10 by means of a suture 41, or similarconnection, and removal of the device from the urethra is accomplishedby gripping and pulling on the plug 25 with a cystoscope or similartool. As was the case on insertion, the collapsible nature of valveassembly 15 and the restricted diameter of tubular body 20 allow thepassing of the device through various restricted areas along theurethra.

Although the above description describes details of a preferredembodiment of the present invention, it will be understood by thoseskilled in the art that numerous other embodiments and applications ofthe invention exist. Although in many such applications, all of theadvantages of the illustrated embodiment may not be achieved, certaindesirable attributes may be attainable. For-example, the length of thedevice may be varied for specific applications and the device need notbe restricted to use in the male urethra, or even to use in humans.Further, the sheath 33 may be omitted in certain situations, in whichcase inflatable bulb 34 seals against the wall of the urethra with theurinary passageway 21 terminating above inflatable bulb 34. Stillfurther, use of the invention will not require two balloons in certainapplications; for example, where migration must be prevented in only onedirection or where one inflatable balloon will prevent movement in morethan one direction. Indeed, inflatable circumferential balloons 11 and12 may each be replaced with one or more inflatable balloons situatedabout the circumference of the catheter body. Flow control mechanism 38may assume numerous configurations which achieve immediate flow of fluidin one direction and delayed or gradual flow of fluid in the oppositedirection.

The collapsible valve of the invention will find use not only inembodiments such as the urethral device described herein but also in anyindwelling situation where a collapsible, expandable valve is desired tocontrol the flow of body fluids. Such situations could include cathetersfor use in blood vessels as well as devices for controllably blockingother body passages, e.g., esophagus or colon.

In the embodiment described herein, the collapsible valve is smallenough to pass through restricted areas of the urethra, particularly thepenile meatus, without significant trauma, and yet, when it is properlypositioned in the bulbous urethra, it may be expanded to a size which iseasily palpable but much too large a diameter to ever pass through suchrestricted areas. Likewise, in other embodiments and applications, thecollapsible and expandable nature of the valve provides easy passage andpositioning as well as expansion to an effective functioning size oncepositioned. The actual mechanism for operation of the valve once inposition is relatively unimportant as long as the collapsing andexpanding features of the valve structure, as a whole, are notcompromised. For example, other means for collapsing, expanding, openingor closing the valve during normal use could utilize magnetic actuators,mechanical actuators, contracting and expanding fluids, compressiblefluids, or other effective devices.

It is to be understood that the invention is to be limited only by theappended claims.

What is claimed is:
 1. An indwelling valving device, comprising:aflexible tubular body having distal and proximal ends and defining alongitudinal passageway therethrough; anchoring means for securing saidbody in place; and collapsible blocking means for blocking saidpassageway, said blocking means operable to collapse by manual pressureto allow fluid flow through said passageway and operable to expand bygradual pressure equalization to again block said passageway when thedesired fluid flow is completed.
 2. An indwelling valving device ofclaim 1, further comprising releasing means operable to release saidanchoring means and enable said device to be removed from the urethra.3. An indwelling valving device of claim 1, further comprising pressureequalizing bleed-back means for delayed closing of said blocking meansafter said blocking means has been actuated to an unblocking position.4. An indwelling valving device of claim 1 wherein said anchoring meansfurther comprises first and second anchoring means.
 5. An indwellingvalving device of claim 4 wherein said first anchoring means securessaid tubular body adjacent the bladder and said second anchoring meansanchors said tubular body adjacent the proximal urethra.
 6. Anindwelling valving device of claim 4 wherein said first and secondanchoring means comprise inflatable members.
 7. An indwelling valvingdevice of claim 6, further comprising valve means for inflating saidinflatable members from said distal end.
 8. An indwelling urinarycontinence device, comprising:a flexible tubular body having distal andproximal ends and having a first passageway extending longitudinallytherethrough; a first fixation means secured to the exterior surface ofsaid proximal end of said body; a second fixation means secured to theexterior surface of said body; and an inflatable member secured withinsaid first passageway, said inflatable member inflatable to close saidfirst passageway and manually compressible to open said firstpassageway.
 9. An indwelling urinary continence device as in claim 8,wherein said first fixation means is inflatable.
 10. An indwellingurinary continence device as in claim 9, further comprising:a secondpassageway extending from the interior of said inflatable member to theinterior of said first fixation means; and differential pressure flowcontroller means in said second passageway enabling rapid balancing ofpressures between said first fixation means and said inflatable memberwhen the pressure in said inflatable member exceeds the pressure in saidfirst fixation means, and enabling a time-delayed balancing of pressureswhen the pressure in the first fixation means exceeds the pressure inthe inflatable member.
 11. An indwelling urinary continence devicecomprising:a tubular body adapted to be inserted in the urethra with oneend extending into the bladder and the opposite end spaced inwardly ofthe meatus, said tubular body having upper and lower portions and saidlower portion defining an annular space when positioned within theurethra; a first inflatable member secured to the exterior surface ofsaid upper portion of said tubular body and positioned to be within thebladder upon inflation; a second inflatable member secured to theexterior surface of said upper portion of said tubular body andpositioned to engage the urethra upon inflation; a third inflatablemember secured to the exterior surface of said lower portion of saidtubular body; and a first passageway in said tubular body to drain saidbladder into said annular space between the urethra and said lowerportion of said tubular body.
 12. The indwelling urinary continencedevice of claim 11, further comprising:a second passageway in saidtubular body extending from the interior of said third inflatable memberto said first inflatable member; and differential pressure flowcontroller means in said second passageway for enabling rapid balancingof pressures between said first and third inflatable members when thepressure in said third inflatable member exceeds the pressure in saidfirst inflatable member, said controller means including means forenabling a time-delayed balancing of pressures when the pressure in saidfirst inflatable member exceeds the pressure in said third inflatablemember.
 13. The device of claim 11 including a collapsible sheathattached along its upper periphery to the periphery of the lower end ofsaid upper portion of said tubular body, said sheath surrounding saidthird inflatable member so as to be collapsible upon insertion of saiddevice but expandable to full diameter when properly positioned.
 14. Thedevice of claim 11 including:a valve chamber in the lower end of saidtubular body vented to provide fluid communication between said valvechamber and each said inflatable member, and between said valve chamberand said urethra; and a valve member operable in said valve chamberbetween a first position in which said vents are all open and a secondposition in which all said vents are closed.
 15. The device of claim 11in which said inflatable members are balloons.
 16. The device of claim11 in which said third inflatable member is positioned to be adjacentthe perineum so as to be easily compressible from the exterior surfaceof the body.
 17. An indwelling urethral device comprising:a tubular bodyadapted to be inserted into the urethra and extend from an upper end incommunication with the bladder to a lower end spaced above the lower endof the urethra; a first balloon at the upper end of said tubular bodyinflatable from the lower end of said tubular body to expand into ananchoring position within the bladder; a second balloon at andinflatable from the lower end of said tubular body to seal against thewall of the urethra; a first lumen in said tubular body communicatingbetween said balloons; flow control means in said first lumen operableto promptly relieve differential pressures above a preselected valuefrom said second balloon to said first balloon; and time delay means forthe gradual release of said differential pressures from said firstballoon to said second balloon.
 18. The device of claim 17, including:ananchor on said tubular body between said balloons pneumatically actuablefrom said lower end of said tubular body to anchor said device withinsaid urethra.
 19. The device of claim 17, including:a second lumen insaid tubular body adapted to drain the bladder into the urethra abovesaid second balloon.
 20. The device of claim 19, including:a valvechamber in the lower end of said tubular body vented to communicate withsaid balloons and said anchor for the passage of fluid therebetween; anda valve operable in said chamber between a first position opening suchvents and a second position closing such vents.
 21. An indwellingvalving device for use in a body passageway comprising:an elongatedmember defining a first longitudinal passageway and adapted to beinserted into said body passageway, said member defining an annulus withthe body passageway; a first expansible member on said elongated membertoward a first end of said elongated member of a character uponexpansion to seal the annulus between said elongated member and saidbody passageway; an inflatable member on said elongated member spacedlongitudinally from said expansible member toward the second end of saidelongated member to block said first passageway upon inflation, andpalpable to expel fluid contained in said inflatable member; aninflatable chamber to receive said expelled fluid; and differential flowcontrol means interconnecting said inflatable member and said inflatablechamber to enable said expelled fluid to flow rapidly from saidinflatable member to said inflatable chamber and to enable fluid to flowmore gradually from said inflatable chamber into said inflatable member.22. The indwelling valving device of claim 21 in which said inflatablechamber is disposed within said first expansible member.
 23. Theindwelling valving device of claim 21 in which said flow control meanscomprises pressure relief means to enable said expelled fluid to flow tosaid inflatable chamber and flow restriction means to enable fluid toflow from said inflatable chamber to said inflatable member.
 24. Theindwelling valving device of claim 21 in which said first passagewayincludes a first section extending internally of said elongated memberfrom said first end to bypass said expansible member and a secondsection comprising said annulus whereby said second section bypassessaid inflatable member upon said expulsion of fluid from said inflatablemember.
 25. An indwelling valve assembly for controlling the flow offluid through a body passageway, comprising:a valve comprising a sheathoperative to expand from a collapsed state to increase the flow areathrough the valve; actuator means for selectively opening said valve;and control means for delayed gradual closing of said valve, said valveassembly operative to allow collapse of said sheath while passing thoughareas of restricted diameter.
 26. A valve assembly as in claim 25,further comprising a valve member inflatable to close said valve.
 27. Avalve assembly as in claim 26, wherein said valve member comprises areceptor for receiving fluid.
 28. A valve assembly as in claim 27,further comprising:a reservoir; and a passageway extending from saidvalve member to said reservoir.
 29. A valve assembly as in claim 28wherein said reservoir is expandable to receive fluid from said valvemember.
 30. A valve assembly as in claim 28, wherein said control meansis responsive to said actuator means to allow fluid in said receptor toflow to said reservoir and responsive to pressure on said reservoir toyieldably resist flow of fluid from said reservoir to said receptor. 31.A device for insertion into the urethra, comprising:a fixation means forengagement with the bladder; a valve for substantially preventing theflow of urine through the urethra; and an interconnecting member forinterconnecting said fixation means and said valve, said valve includinga sheath operative to collapse upon passage of the device through areasof restricted diameter and expand upon proper positioning in the urethrato increase the flow area through said valve.
 32. A urethral valvingdevice, comprising:a valve operable to collapse upon insertion into orwithdrawal from the urethra and expand while in a position within theurethra; and means for selectively opening said valve from a pointexternal of the body.
 33. The device of claim 32, furthercomprising:means for automatic delayed closing of said valve after saidvalve has been opened.
 34. The device of claim 32, further comprising:achamber vented to provide fluid communication between said chamber andsaid valve and between said chamber and said urethra; and a plugoperable in said chamber between a first position in which said ventsare open and a second position in which said vents are closed.
 35. Anintraurethral valving device, comprising:a flexible tubular body havingdistal and proximal ends and defining a longitudinal passagewaytherethrough; anchoring means for securing said body in place; blockingmeans for blocking said passageway; a valve chamber in said distal endof said body having vents to provide fluid communication between saidvalve chamber and said anchoring means, between said valve chamber andsaid blocking means, and between said valve chamber and said urethra;and a valve member operable in said valve chamber between a firstposition in which said vents are all open and a second position in whichsaid vents are all closed.